Status:
COMPLETED
A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.
Eligibility Criteria
Inclusion
- Male or female patients (18 years)
- Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II)
Exclusion
- Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
- Pregnant or nursing women
- Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 140 mmHg)
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00392262
Start Date
August 1 2006
End Date
February 1 2007
Last Update
November 18 2016
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis
Basel, Switzerland